FDA.reportPublic FDA data

EPITOPE DIAGNOSTICS, INC.

Matched from indexed company URL: EPITOPE DIAGNOSTICS INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20328393004185580EPITOPE DIAGNOSTICS, INC.1N2026-01-0117034 Camino San Bernardo SAN DIEGO CA US 92127

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00893230002032EDI™ CARE™ - Fecal Occult Blood Test858 693-7877cs@epitopediagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
626991574698619K051806CARE FECAL OCCULT BLOOD TEST, MODEL KT313KHE2005-10-03
626991004830412
626991106865428
626991139208357
626991149652365
626991175186598
626991189431241
626991213316872
626991220355915
626991343695648
626991371450599
626991397960195
626991464219841
626991540895117
626991591213165
626991609516366
626991686029273
626991697205208
626991708765225
626991727593349
626991771018565
626991833040944
626991866395547
626991928925078
626991940566807
626991995838177
626991059748610
626991071344850
626991075592069
626991107009424
626991137564629
626991148308175
626991149052912
626991172839145
626991178579963
626991214202561
626991225972552
626991256401640
626991315823119
626991333765877
626991371521381
626991378218280
626991494967022
626991556643303
626991570559912
626991586534646
626991589606493
626991592920961
626991593588464
626991600067164
626991626445366
626991628117328
626991685135123
626991688363011
626991690440627
626991709713265
626991725826005
626991758663427
626991773560361
626991775465291
626991777864129
626991779264299
626991807779879
626991822152472
626991832342358
626991853880337
626991856215728
626991872285728
626991878808236
626991882455849
626991909303607
626991918362280
626991929692931
626991937755480
626991938076212
626991941226206
626991943040611
626991964875760
626991969316761
626991990468825
626992008953905
626992014027183
626992034350902
626992038598500

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KHE22005-10-03

PMN#

GUDID#